QC Planning & Laboratory Systems Specialist

Job Description

The QC Planning & Laboratory Systems Specialis t is responsible for the end-to-end planning, coordination, and optimization of Quality Control (QC) Release and Stability laboratory activities supporting manufacturing operations.

This role combines laboratory planning, capacity management, data analysis, and laboratory systems expertise to ensure efficient sample flow, optimal resource utilization, and on-time execution of testing activities within a regulated environment.

The successful candidate will manage laboratory demand planning, capacity forecasting, scheduling, KPI reporting, and contract laboratory coordination while leveraging GLIMS and related digital tools to drive operational excellence and continuous improvement.

We are looking for a proactive and collaborative individual who can deliver results in a dynamic environment, leverage data to drive decisions, champion quality and compliance, and contribute to continuous improvement and digital transformation initiatives across QC Operations.

Primary Responsibilities

Laboratory Planning & Scheduling

• Develop and maintain integrated laboratory plans supporting QC Release, Stability, Validation, PPQ, and ad hoc testing activities.

• Coordinate sample demand forecasts and testing priorities with Manufacturing, Supply Chain, Quality Assurance, Stability, and other stakeholders.

• Create and maintain daily, weekly, monthly, and long-range laboratory schedules.

• Balance laboratory workloads across analysts, instruments, testing streams, and contract laboratories.

• Monitor execution against laboratory schedules and proactively identify risks, bottlenecks, and capacity constraints.

• Support prioritization of laboratory activities to ensure critical business timelines are achieved.

Capacity Planning & Resource Management

• Develop and maintain laboratory capacity models incorporating analyst availability, instrument utilization, sample volumes, and turnaround time requirements.

• Conduct short-, medium-, and long-term forecasting to support operational and strategic planning.

• Perform scenario planning and risk assessments to support changing manufacturing demands and business priorities.

• Collaborate with laboratory leadership to identify resource requirements and mitigation strategies.

Laboratory Systems & Data Analytics

• Utilize GLIMS or equivalent LIMS and associated laboratory systems to support sample management, scheduling, reporting, and operational planning activities.

• Support continuous enhancement of laboratory planning tools, workflows, and digital solutions.

• Develop, track, and analyze laboratory KPIs including turnaround time, throughput, workload, schedule adherence, and capacity utilization.

• Generate reports, dashboards, and performance metrics using Microsoft Excel, Power BI, and other business intelligence tools.

• Translate laboratory data into actionable insights to support operational decision-making and continuous improvement.

Contract Laboratory Coordination

• Coordinate external contract laboratory testing activities and associated deliverables.

• Monitor contract laboratory performance against agreed timelines and service level expectations.

• Identify and escalate risks while supporting the implementation of mitigation plans.

• Support effective workload balancing between internal and external testing resources.

Quality & Continuous Improvement

• Ensure planning activities comply with GMP requirements, company procedures, and quality standards.

• Support inspection readiness activities as required.

• Participate in continuous improvement and laboratory digitization initiatives.

• Identify opportunities to simplify, standardize, and improve planning processes.

• Promote a culture of compliance, quality, and operational excellence.

Qualifications, Skills & Experience

Required

• Bachelor's Degree in Science, Engineering, Supply Chain, Business, or a related discipline.

• 3+ years' experience in a regulated pharmaceutical, biotechnology, life sciences, diagnostics, medical device, or laboratory environment.

• Experience supporting Quality Control laboratory operations, planning, scheduling, or capacity management activities.

• Experience using GLIMS or another Laboratory Information Management System (LIMS).

• Advanced Microsoft Excel skills.

• Strong analytical, planning, and problem-solving capabilities.

• Excellent communication and stakeholder management skills.

Preferred

• Experience supporting QC Release or Stability laboratories.

• Experience in biologics manufacturing or testing environments.

• Experience with Power BI, dashboard development, or data visualization.

• Experience in laboratory digitization or continuous improvement initiatives.

• Experience with capacity modelling or contract laboratory coordination.

• Knowledge of GMP, data integrity, investigations, and CAPA processes.

Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities - from our Company in Ireland to the world.

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

Required Skills:

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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